Unique Device Identification (UDI) Requirements, deadlines, secure labeling The implementation of the UDI Directive is mandated for medical device manufacturers. This is not only true for companies that sell their products on the American market, since UDI is also being implemented in the EU and other countries. Medical products must be clearly identified to ensure safe traceability and patient safety. In addition to the marking of packaging and labels, this also applies to the direct marking of high risk products such as implants and instruments. Manufacturers must maintain deadlines and requirements to implement marking systems to apply marking in accordance with UDI requirements and medical standards. In order to implement the demanding labeling, serialization and marking requirements, appropriate technologies are required that allow the codes to be applied and checked with high resolution, permanence with exceptional quality and, if necessary, even in the smallest of spaces.

Medical Industry White Paper

Unique Device Identification (UDI)

Requirements, deadlines, secure labeling

The implementation of the UDI Directive is mandated for medical device manufacturers.

This is not only true for companies that sell their products on the American market, since

UDI is also being implemented in the EU and other countries. Medical products must be

clearly identified to ensure safe traceability and patient safety. In addition to the marking

of packaging and labels, this also applies to the direct marking of high risk products such as

implants and instruments. Manufacturers must maintain deadlines and requirements to

implement marking systems to apply marking in accordance with UDI requirements and

medical standards. In order to implement the demanding labeling, serialization and

marking requirements, appropriate technologies are required that allow the codes to be

applied and checked with high resolution, permanence with exceptional quality and, if

necessary, even in the smallest of spaces.

Laser marked UDI-Codes

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U.S. Food and Drug Administration

Logo Sheet 1298.01

The UDI program:

Consistent labeling of medical devices for an increase in patient safety and transparency in the supply chain

The UDI system will go into effect in stages, over a period of seven years, based on product risk level, starting with the products with the highest risk class. The directive applies initially to the American market – that is to say for medical products and devices that are produced or imported and are distributed in the USA – but is also being introduced in other countries. Plans are underway to anchor the labeling requirement in the new European Medical Device Regulation as well.

The declared goal of the UDI system is to increase patient safety and optimize patient care. The UDI system addresses all of the following aspects:

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More efficient product recalls

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Improved counterfeiting protection

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Simplification of data entry and accessibility with different systems

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Security throughout the entire supply chain

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Field Safety Corrective Actions – FSCA

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Better identification, documentation and prevention of incidents

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Reducing the chances of medical errors occurring (by quick and concise product identification, and the ability to easily obtain important product information > Reducing number of misapplications)

Additionally, the labeling system allows for the simplification of logistics, ordering and delivery processes.

In 2013, the FDA (Food and Drug Administration) released the UDI Directive for the

uniform labeling of medical devices with the marking specification in its "final rule".

Standardized labeling is meant to enable the complete identification and tracking of

medical devices throughout the entire product life cycle. The European Union and

other countries are planning similar regulations.

UDI -Kennzeichnung von Medizinprodukten

In the near future:

UDI in the EU – Medical Device Regulation (MDR) and "system of a unique product number"

In Europe, the implementation and introduction of a UDI regulation is the responsibility of the European Commission. For a long time, uniform guidelines for the traceability of medical devices did not exist; the various member countries developed different regulatory mechanisms, or did not regulate traceability at all. (See Official Journal of the European Union > 2013/172/EU, L 99/17)

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In its proposal for a regulation on medical devices

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, the

European Commission created Chapter III of the "Identifi- cation and Traceability of Products". Article 24 deals with the "system of the unique product number", which is intended to enable the identification of medical products and facilitate their traceability. This is not intended to regulate all aspects of the UDI system, but concerns itself more with the compatibility of the traceability mechanisms at the national and/or regional level and the introduction of an obligatory, internationally compatible UDI system (see Amtsblatt der Europäischen Union > 2013/172/EU, L 99/18)

In the EU, the UDI directive will be introduced as a "Unique Device Identification"* system

within the framework of the new European Medical Device Regulation (Medical Device

Regulation - MDR). First steps have already been taken in this direction; the regulation is

increasingly taking form.*

Currently: CE marking

Currently, medical products – in order to be marketed or put into service on the European market – must bear a CE marking. This can only be applied if a conformity assessment procedure demonstrates that the product complies with the basic safety and performance requirements laid down in the relevant Euro- pean directives. Previously, it is required to pass a risk manage- ment process, a clinical evaluation and a risk-benefit analysis.

The conformity assessment procedure must be carried out in accordance with the risk class of the medical device, with the participation of a privately operating, independent testing and certification body (known entity) which is subject to a state

designation and reports to the appropriate authority. Only at the lowest risk class I can the manufacturer carry out the procedure under their own responsibility

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CE marking and conformity declarations document

compliance with essential safety and performance requirements and are a prerequisite for medical devices to have access to the EU market

Background

The UDI system has emerged from an initiative set by the legis- lators of the countries that form the

IMDRF

(International Med-

ical Device Regulatory Forum). As the first membership country in the IMDRF to do so, the US implemented the UDI system, with the start date of 24 September 2014, into law.

The implementation is the responsibility of the FDA (Food and Drug Administration) and currently concerns medical products sold in and imported into the American market.

The UDI regulation will be introduced with the new European Medical Devices Regulation and will apply to all medical products and will require that they be re-certified (MDR certificate). For manufacturers this means (among other things):

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technical documentation has to be revised

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each product must be assigned a unique product identification number ("unique device ID")

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manufacturers must register themselves and EU-marketed products in the EU database EUDAMED

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medical products may have to be re-labeled and marked (per the new legislation, after the respective transition period, products will be required to carry a certificate when they are first brought to market in the EU).

The new MDR is expected to be enforced in March 2017. Depending on the risk class, UDI codes that have to be applied directly on the device have to be implemented between 3 to 7 years after date of application (2020) – from 2023 to 2027.

The UDI system is phased in in stages based on product classification risk level,

starting with the products with the highest risk class. Find below the labeling

deadlines for products manufactured in or imported into the United States.

UDI marking of medical devices

UDI codes on packaging or as direct marking:

What has to be marked where?

Where and when a UDI code has to be applied to a product depends on its

nature (risk class) and intended use. The UDI system differentiates between the

marking of the packaging or labels and direct marking on the product.

09.2014

09.2015

09.2016

09.2018

09.2020

Class III

labels, packages

direct marking¹

Implantable, life-saving, life-sustaining

labels, packages

direct marking¹

Class II

labels, packages

direct marking¹

Class I and non-classified

labels, packages

direct marking¹

The last deadline for the marking of packaging and labels will be reached in 2018. At that point, the packaging and labels of all class I-III products must carry a UDI code in plain text and machine-readable form, using automatic identifi- cation and data collection (AIDC) technology ab.

→ Labels and packages of implantable, life-supporting, and life-sustaining devices (21 CFR 801.20) → Life-supporting or life-sustaining devices that are required to be labeled with a UDI must bear a

UDI

as a permanent marking on the device itself

if the device is intended to be used more than once and

intended to be reprocessed before each use (21 CFR 801.45) → Compliance date extension for single use implants that are intended to be sterilized or cleaned and sterilized before use) to September 2016¹

high risk, general controls and premarket approval, life-saving and life-sustaining

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bandages

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stethoscope

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surgical scissors

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dental floss

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mechanical wheelchair

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Infusion pumps

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surgical sutures

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bone screws

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syringe

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condoms

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powered wheelchair

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heart valves

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knee prosthesis

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pacemaker

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automated external

defibrillators

Medical device classification differs in the USA and the EU. The EU distinguishes four classes (Class I, IIa and IIb and III) for low to high risk. In the US, the FDA has defined three risk classes based on the degree of control needed to guarantee the safety and efficacy of the products.

According to the FDA, direct marking is required for implants and those devices intended to be reused over an extended pe- riod of time (several months or years) and require reprocess- ing (i.e. sterilization) before each use, as these will necessarily be separated from the original packaging.

FDA risk categories

¹) if reused and reprocessed

Implants and Class III products do not necessarily have to bear a directly marked UDI code. No directly marked UDI is required for sterile packaged implants that are unpacked directly at the implant site. A directly marked UDI code is only required if the corresponding products are processed (for example, cleaned, sterilized or passivated) before their use. Instruments that are repeatedly used and reprocessed must – depending on risk class – carry a permanent UDI code by 2020 at the latest.

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Reliable and unique:

Code format, coding system and issuing agencies

According to 21 CFR 81.40, medical devices have to carry a UDI that is represented in two forms:

In case the UDI code is applied as a permanent direct mark, it must be in either or both (1) easily readable plain-text and (2) AIDC form or alternative technology (see 21 CFR 801.45).

Clear regulations apply for UDI codes, since only a uniform code

format and reliably readable marks and labels ensure reliable

traceability.

UDI marking of medical devices

Code format: UDI = DI + PI

UDI code examples

The UDI code in the AIDC form (linear bar code or Data Matrix Code) is not a new code format, but uses existing standards. However, some preconditions have to be fulfilled:

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A UDI must be issued by a FDA-accredited issuing agency

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The Unique Device Identifier must conform to international ISO standards (ISO/IEC 15459–2, ISO/IEC 15459–4, ISO/IEC 15459–6) and may only use characters and numbers from the invariant character set of ISO/IEC 646 standard (see 21 CFR 830.20).

The FDA has accredited three organizations as UDI Issuing Agencies:

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GS1

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HIBCC (Health Industry Business Communications Council)

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ICCBBA (International Council for Commonality in Blood Banking Automation).

Both, the Health Industry Barcode (HIBC) and the GS1 code are equally suitable for the UDI compliant marking of medical products and devices. With the ISBT 128, the ICCBBA offers a special system for products of human origin (blood, trans- plants).

Coding system und issuing agency

GS1-128 linear bar code

GS1 DataMatrix code

Primary code DI (Device Identifier)

Secondary code PI (Production Identifier)

(01)47964367965424(11)173434(17)226565(10)A379B3(21)1237

machine readable

human

readable

(01)47964367965424

(11)173434

(17)226565

(10)A379B3(21)1237

machine readable

human readable

HIBC linear bar code

HIBC DataMatrix code

Primary code DI (Device Identifier)

Secondary code PI (Production Identifier)

+ELMI A20272 1/ $ B9030011/ S ACF7 C

machine readable

human

readable

+ELMI A20272 1/ $

B9030011/ S ACF7 C

machine readable

human readable

The Unique Device Identifier consists of two parts, the Device Identifier (DI) and the Production Identifier (PI). An exception are Class I medical devices, for which the labeling with the Production Identifier is not required.

The Device Identifier (DI) is the mandatory, fixed portion of a UDI that identifies the labeler and the device (specific version or model). The DI contains the following static information:

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Identifies the manufacturer/labeler

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Specific version or model of device (also reference code)

This information serves as the key to obtain device informa- tion in the UDI database (GUDID). The DI is a globally unique product code which allows for the clear identification of a device.

The Production Identifier (PI) is a conditional, variable por- tion of a UDI that identifies one or more of the following when included on the label of a device:

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Lot and batch number (GS1 > 10)

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Serial number (GS1 > 21)

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Expiration date (GS1 > 17)

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Date of manufacture (GS1 > 11)

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Unique code for a human cell, tissue, or cellular or tissue- based product

The selection of the related data elements depends on the product (i.e. batch management requirement). The PI data are only deposited in the code, they are not part of the GUDID. The GUDID only tells if they are “existing” or “not existing”. The format YYYY-MM-DD applies for all dates in text form (HRI, Human Readable Interpretation), for example, March 2, 2017 must be represented as 2017-03-02 (see 21 CFR 801.18).

UDI code/unique device identifier (DI+PI)

Fictitious example of what a unique device identifier (UDI) would look like on a medical device label.

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GUDID:

The central UDI database

According to the UDI final specification, the manufacturer and labeler of each medical device labeled with a unique device identifier (UDI) must submit in- formation concerning that device to the GUDID. Such device identification information can be submitted either via GUDID Web Interface or as a xml file.

The GUDID contains only the data of the device identifier (DI), the variable data of the UDI PI (Product Identifier) are exclusively on file in the code. How- ever, the GUDID contains production identifier flags to indicate which PI at- tribute(s) are on the device label.

Once a device is registered in the GUDID, both the public and all stakeholders engaged in the production and usage can access information contained in the GUDID. The GUDID will be linked to databases around the world and will thus gain global influence.

UDI-Kennzeichnung von Medizinprodukten

Secure and reliable product identification marking

Challenges and solutions for manufacturers and labelers

The center of the American UDI system is the "Global Unique Device

Identification Database" (GUDID) that serves the registration and as a

reference catalog for every device with an identifier. The EU's equivalent

is the EUDAMED.

The requirements for the identification of medical devices are high. What is

more, are the special requirements on the UDI labeling. Innovative marking

systems not only solve these challenges but also contribute to an increase in

production efficiency and improved product quality.

The requirements on the marking of medical devices are extremely stringent. Marks have to be...

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permanent and traceable,

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legible and readable,

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high in contrast,

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counterfeit-proof,

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sterilization-resistant,

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hygienic, clean, biocompatible

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and in the case of metals such as stainless, corrosion- resistant.

Due to the high demands on data quality of UDI codes, the requirements for code readability, and as such the marking quality, are especially precise.

UDI codes have to be readable

free of error

– only then can the required unique, consistent,

traceability be ensured. This assumes that the marking itself is error-free. The following points must be guaranteed:

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The correct product must be marked with the correct code (product conform).

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The mark must be correctly positioned.

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The code needs to legible over the long term (both plain text and machine readable).

Many manufacturers apply vision systems for code validation. Aspects tested include; legibility, contrast, code positioning and the accuracy of the encoded data. Marking systems with machine-integrated imaging are particularly efficient. They save additional process and product handling steps outside the marking system, as marking quality and marked contents are verified directly in the marking station. Furthermore, the positioning of the mark turns out to be highly precise when aligned by the integrated camera system before the marking takes place.

As the device marking is often one of the last production steps, the direct marking must be applied reliably and safely. In this late manufacturing stage, product scrap due to incorrect markings is particularly costly. If marking errors can be corrected, the correction is time-consuming and cost- intensive. If they can't be corrected, the device itself has to be scrapped. Using pre- and post marking image-assisted validation and verification steps executed directly within the marking system itself, as well as automatic mark alignment, a machine-integrated vision system enables stable marking processes and reliable, error-free marking results. The advantages are obvious and include an increase in efficiency and product quality and a decrease in scrap.

Benefits of vision-assisted marking solutions

Requirements on marking systems

→ Further information on the database and data transfer: http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ UniqueDeviceIdentification/ GlobalUDIDatabaseGUDID/default.htm

UDI codes on a suction catheter (left) and on a balloon catheter (right)

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FOBA White Paper

UDI marking of medical devices

Making the right choice:

Marking technology for product marking

One of the major challenges facing UDI is the implementation of the appropri-

ate direct marking technology. The FDA does not specify which of the various

available options should be used. Moreover, not every method is suitable for

secure and UDI-compliant direct part marking; therefore choosing the best

method to meet the requirements can be difficult and is crucial.

The table shows standard marking methods with criteria rele- vant for the marking of medical devices with UDI codes.

¹) if used correctly ²) from <1mm² to 400x400mm ³) label attachement method

Above all, laser marking is ideally suited for the direct marking of medical devices with the Unique Device Identifier. It fulfills all the criteria relevant for safe product marking based on medical standards and UDI requirements.

→ The laser-based marking of medical products with the system, process and inte- grated vision solutions that FOBA offers provides many advantages over alterna- tive methods. We look forward to meeting with you for a live demonstration at our application lab or at your site, and are happy to provide you with free sample marking on your material. Contact us:

info@fobalaser.com

Laser marking is ideal for direct part marking (DPM) to meet the UDI standard and is

ideally suited for serial applications with variable data and for mass production. The laser

produces high-quality, permanent, readable markings on products and packaging and

ensures the highest precision and process stability when combined with integrated vision